MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-08-15 for TERUFLEX BLOOD BAG SYSTEM 1BBAGD506A3 manufactured by Terumo Corporation/terumo Bct.
[4691058]
The customer reported at the end of a collection procedure, the operator was sprayed with blood. While disconnecting the donor, the needle guard was not properly engaged and the blood from the needle got onto the operator's arm. Per physician's order, diagnostic test were given and are awaiting on test results. The patient (operator) is reported in healthy condition. Donor unit #: (b)(6). The customer declined to provide patient's (operator) identifier and weight. The disposable kit is not available for return because it was discarded by the customer. This report is being filed due to device malfunction in the form of operator error that has the potential for death or injury if the same failure were to recur.
Patient Sequence No: 1, Text Type: D, B5
[11950326]
Investigation: the customer stated that is a training issue. Terumo bct will follow-up with the customer. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[34321096]
This report is being filed to provide additional information. Investigation: the disposable was unavailable for investigation. A 100% visual inspection is conducted for the donor care needle guard after assembly. The manufacturing and testing records were reviewed, with no anomalies observed. Four retention samples were examined and tested for full needle retraction into the donor care needle guard. All samples retracted according to manufacturing specification. The supplier of the donor care needle guards investigated their test records and manufacturing records of the lot upon request. No anomalies were found by the supplier in their records. Root cause: operational problem correction: a terumo bct clinical specialist attended a staff meeting at the customer site and demonstrated the proper way to hold the needle guard without needle sticks. Also, the staff was shown 2 training videos regarding the safe handling of the donor care needle guard. These videos were provided to the director/manager for future training purposes.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1722028-2014-00329 |
| MDR Report Key | 4013793 |
| Report Source | 05 |
| Date Received | 2014-08-15 |
| Date of Report | 2014-07-16 |
| Date of Event | 2014-05-08 |
| Date Mfgr Received | 2014-07-16 |
| Date Added to Maude | 2014-08-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JESSICA KIM |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314812 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUFLEX BLOOD BAG SYSTEM |
| Generic Name | TERUFLEX DOUBLE BLOOD BAG 500ML COLLECTIONS BAG |
| Product Code | KSR |
| Date Received | 2014-08-15 |
| Catalog Number | 1BBAGD506A3 |
| Lot Number | 130325GB |
| Device Expiration Date | 2015-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TERUMO CORPORATION/TERUMO BCT |
| Manufacturer Address | FUJINOMIYA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-08-15 |