MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN; SYRINGE

Catalog Number UNKNOWN

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Inflammation (1932); Injury (2348)

Event Date 09/21/2015

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown.The date received by the manufacturer is used.The clinician used the following two devices but it is unknown which is the suspect device for this incident.1) medical device brand name: bd slip tip 5ml syringe, catalog # 302130, lot # 5110125, device manufacture date: 4/20/2015, device expiration date: 4/30/2020.2) medical device brand name: bd slip tip 10ml syringe, catalog # 302143, lot # 5110136, device manufacture date: 4/20/2015, device expiration date:04/30/2020.This device does not have a 510(k)#.A supplemental report will be submitted upon completion of the investigation.A sample is available for investigation but not yet received.

Event Description

It was reported that while using a bd syringe, the clinician experienced difficulty moving the plunger.As a result, the clinician experienced an injury and inflammation to her hand.She went to the doctor and had three unspecified medication injections to her hand.

Manufacturer Narrative

Result - two unused samples were returned for catalog 302130, lot 5110125.Three unused samples were returned for catalog 302143, lot 5110136.From the returned samples, the breakout and sustaining force is within the product specifications.No defect is observed on the returned samples.Conclusion - an absolute root cause for this incident cannot be determined.

Manufacturer Narrative

No sample has been received to date.If a sample is returned, an evaluation will be performed and an additional supplemental report will be filed.Complaint history check yielded no other complaints for similar condition for the lot reported.A review of the device history record revealed no abnormalities during the manufacture of the reported lot numbers 5110125 and 5110136.Conclusion: without a sample, an absolute root cause for this incident cannot be determined.

• Brand Name: UNKNOWN
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5154862
• MDR Text Key: 28446098
• Report Number: 8041187-2015-00013
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: TH
• 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: Health Professional
• Type of Report: Followup,Followup
• Report Date: 12/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 50 YR