MAUDE Adverse Event Report: BECTON DICKINSON BD¿ ONE-PIECE SHARPS COLLECTOR

Catalog Number 303205

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/24/2015

Event Type  Injury  

Manufacturer Narrative

Medical device expiration date: n/a.Medical device manufacturer: vip packaging.(b)(4).Initial reporter phone #: (b)(6).Pma / 510(k) #: there is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A sample is not available for evaluation, however, a photo of the device was received and evaluated.The photo shows that a needle had pierced through the sharps container.Representative retention samples were also evaluated and both cavities were examined, in particular the region of the penetration.Cavity one measured 1.39mm in wall thickness and cavity two measured 1.33mm in wall thickness.These measurements are well above the minimum requirement of 1.17mm.A review of the device history record revealed no irregularities during the manufacture of the reported lot number 15126001.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.Device not returned for evaluation.

Event Description

It was reported that a needle of unknown origin penetrated the corner of a bd one-piece sharps collector and a nurse brushed up against the exposed needle with her leg.The nurse did not receive any prophylactic treatment as it was determined that the needle scraped her and did not penetrate deeply.The nurse received routine post exposure lab work and will receive monthly post exposure lab work for three months.

• Brand Name: BD¿ ONE-PIECE SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5085725
• MDR Text Key: 26114021
• Report Number: 2243072-2015-00160
• Device Sequence Number: 0
• Product Code: MMK
• Reporter Country Code: AS
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 303205
• Device Lot Number: 15126001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other