MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-08 for TERUFLEX DRY COLLECTION BAG 1BBD606A manufactured by Terumo Corporation/terumo Bct.
[19602483]
The customer reported a needle stick injury that occurred when a nurse was recapping the needle using a one handed technique after a therapeutic phlebotomy on a patient with hemachromatosis. Per the customer, the nurse will undergo the hospital's blood exposure protocol. The nurse is reported in healthy condition. The patient's (nurse) age and weight are unavailable at this time. The disposable set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5
[20137629]
Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10
[31795747]
Investigation: the set was not returned for investigation. The manufacturing and testing records were reviewed with no issues noted. No anomalies were observed in the phlebotomy needle part of the product. Reserve samples for this lot were visually examined with no anomalies noted. No similar reports have been received regarding this lot number. Root cause: the root cause for this needlestick injury is undetermined.
Patient Sequence No: 1, Text Type: N, H10
[31795748]
The customer declined to provide patient's (nurse) age and weight.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1722028-2015-00177 |
| MDR Report Key | 4760285 |
| Report Source | 05 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-04-15 |
| Date of Event | 2015-04-15 |
| Date Mfgr Received | 2015-05-19 |
| Date Added to Maude | 2015-06-08 |
| 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 | GLENDA O'NEILL |
| Manufacturer Street | 10811 W. COLLINS AVE |
| Manufacturer City | LAKEWOOD CO 80215 |
| Manufacturer Country | US |
| Manufacturer Postal | 80215 |
| Manufacturer Phone | 3032314051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TERUFLEX DRY COLLECTION BAG |
| Generic Name | TERUMO BLOOD BAG WITHOUT ANTICOAGULANT |
| Product Code | KSR |
| Date Received | 2015-05-08 |
| Catalog Number | 1BBD606A |
| Lot Number | 120718F3 |
| Device Expiration Date | 2015-06-01 |
| 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 | 2015-05-08 |