MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-07-12 for 5 ML BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5 ML 306424 manufactured by Bd Medical (bd West) Medical Surgical.
[113871237]
Two lot numbers were provided for this incident. The information for each lot number is as follows: medical device lot #: 729690n, medical device expiration date: 10/31/2019, device manufacture date: 10/23/2017. Medical device lot #: 802967n, medical device expiration date: 1/31/2020, device manufacture date: 1/29/2018. Investigation: no samples were provided for evaluation. There was no documentation of issues for the complaint of these batch #s during this production run. All our inspections performed while manufacturing these batch #s was accepted; no rejections were documented. Controls in place at the manufacturing site: bioburden tested on a weekly basis. An overkill sterilization process is used. Environmental testing within the filling area is done on a biweekly basis. The sterilization process is challenged and re-qualified annually. The solution is filtered twice before it is filled in syringes (note: once when transferring to the hold tank and again at the fill machine). Endotoxin testing is performed on each batch. Fill room operators are trained and qualified on gowning for the fill room environment on an annual basis. Weekly bioburden testing on the components used to assemble the syringes. Continuous online monitoring of the wfi (water for injection) water quality (note: this is for toc (total organic carbon) and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp (united states pharmacopeia) purified water and wfi systems. Weekly endotoxin testing of the pure steam system. Each sterilizer is thoroughly validated before use for posiflush sterilization. A three year review of complaints, environmental monitoring results, water testing results, and quality notifications have confirmed that the serratia marcescens organism has not been recovered in the columbus ne plant. In addition, the posiflush product produced within columbus is terminally sterilized through steam sterilization which is requalified annually. Furthermore, there is no morphological evidence of serratia marcescens ability to survive the steam conditions1 used to sterilize the posiflush product manufactured in the columbus & drogheda plants. For validation, bd columbus & bd drogheda uses the spore forming, rod-shaped, gram-positive, thermophile geobacillus stearothermophillus as our biological indicator, along with bacillus atrophaeus. The formation of endospores has not been reported in any species of serratia, thus its resistance to steam sterilization is scientifically remote, further it is a motile organism with growing temperatures ranging from 5? 40? C, which is well below our >121? C processing temperatures. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends. Product within specification? Yes? No?. Root cause could not be determined. There were no qns issued during the production of these two batches listed in the complaint. All inspections and testing were accepted during the production of these batches.
Patient Sequence No: 1, Text Type: N, H10
[113871238]
It was reported that a customer was diagnosed with sepsis three times and went into septic shock. The patient fell ill on (b)(6) 2018 was admitted into icu on (b)(6) 2018 for five days. Infection was cleared each time and line was replaced. Blood cultures tested (b)(6) for serratia marcescens for the third time within two months since (b)(6) 2018. The patient associated a 5 ml bd posiflush? Heparin lock flush syringe, 500 usp units/5 ml with this incident. Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush? Heparin lock flush and bd? Pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium. Bd was notified by the u. S. Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s. Marcescens bacterium. Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s. Marcescens across multiple states. Cdc? S initial investigation found that affected patients had received treatment using certain bd flush products. To date, there is no evidence of bd flush product testing (b)(6) for this bacterium. Investigations are ongoing by bd, fda, and cdc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00383 |
| MDR Report Key | 7684414 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-07-12 |
| Date of Report | 2018-08-30 |
| Date of Event | 2018-04-01 |
| Date Mfgr Received | 2018-06-18 |
| Date Added to Maude | 2018-07-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652845 |
| Manufacturer G1 | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Street | 1852 10TH AVENUE |
| Manufacturer City | COLUMBUS NE 68601 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68601 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5 ML BD POSIFLUSH? HEPARIN LOCK FLUSH SYRINGE, 500 USP UNITS/5 ML |
| Generic Name | PREFILLED HEPARIN FLUSH SYRINGE |
| Product Code | NZW |
| Date Received | 2018-07-12 |
| Catalog Number | 306424 |
| Lot Number | SEE H.10. |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL (BD WEST) MEDICAL SURGICAL |
| Manufacturer Address | 1852 10TH AVENUE COLUMBUS NE 68601 US 68601 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-07-12 |