MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,other report with the FDA on 2018-05-31 for BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE 306424 manufactured by Bd Medical (bd West) Medical Surgical.
[109695433]
The date received by manufacturer has been used for this field. Investigation summary: no samples were available to bd for evaluation. Therefore, a quality engineer was unable to perform a thorough investigation regarding the reported reaction. However, an engineer was able to review the inspections performed at the manufacturing facility and found no rejections. Bd has controls in place to reduce any chance of contamination. There are weekly bioburden tests, an overkill sterilization process, biweekly environmental testing within the filling area, the solution is filtered twice before the syringes are filled, once when transferring from the hold tank and again at the fill station, endotoxin testing performed on each batch and the pure steam system, continuous online monitoring of the wfi water quality and each sterilizer is thoroughly validated before being used for posiflush sterilization. However, without a sample to investigate bd was unable to determine a possible root cause for this issue. A device history review was performed on the reported lot and it revealed zero documented issue found during this production run. Complaints received for this product and condition will continue to be tracked and trended. Information will be captured on trend reports and monitored. Our business regularly reviews the collected data for identification of emerging trends. Investigation conclusion: dhr/bhr review there was no documentation of issues for the complaint of batch # 732597n during this production run. Investigation comments: all our inspections performed while manufacturing this batch # were 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 quality (note: this is for toc and conductivity, not microbial - weekly bioburden and endotoxin testing of the usp purified water and wfi systems. - weekly endotoxin testing of the pure steam system. - each sterilizer is thoroughly validated before used for posiflush sterilization. Product within specification? Yes / no. Root cause description: root cause could not be determined. There were no qns issued during the production of this batch # listed in the complaint. All inspections were accepted during the production of this batch. There was no issue documented. Root cause is unknown. Rationale: capa not required for this event.
Patient Sequence No: 1, Text Type: N, H10
[109695434]
It was reported that the customer experienced nausea/ vomiting, clammy pale chills and low fever while using the bd posiflush heparin lock flush syringe. Found during use. The customer consulted with his physician dr (b)(6) and was given nausea medication and instructed to go to the emergency room if symptoms get worse.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1911916-2018-00246 |
| MDR Report Key | 7557848 |
| Report Source | CONSUMER,OTHER |
| Date Received | 2018-05-31 |
| Date of Report | 2018-06-13 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2018-05-10 |
| Device Manufacturer Date | 2017-11-21 |
| Date Added to Maude | 2018-05-31 |
| 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 |
| Reporter Occupation | PATIENT |
| 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 | BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE |
| Generic Name | FLUSH SYRINGE- HEPARIN |
| Product Code | NZW |
| Date Received | 2018-05-31 |
| Catalog Number | 306424 |
| Lot Number | 732597N |
| Device Expiration Date | 2019-11-30 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| 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. Required No Informationntervention | 2018-05-31 |