MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ 3ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number 990418

Device Problem Bent (1059)

Patient Problem Needle Stick/Puncture (2462)

Event Date 06/13/2017

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.(b)(6).There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that a user of a bd plastipak 3ml veterinary syringe with 22g x 1" needle suffered a needle stick injury during use.While administering a vaccine to an animal, the syringe plunger bent causing the needle stick.It was also reported that medical intervention were not deemed necessary for this incident.

Manufacturer Narrative

Results: one used sample was returned for evaluation.A visual inspection revealed a broken plunger rod.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6249170.Conclusion: although bd's visual inspection confirmed the customer's reported defect, an absolute root cause for this incident cannot be determined.Additionally, our quality engineer notes that potential causes could be inadequate airflow at the barrel feeder or bad positioning of air nozzles.

• Brand Name: BD PLASTIPAK¿ 3ML VETERINARY SYRINGE WITH 22G X 1" NEEDLE
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6687804
• MDR Text Key: 79117421
• Report Number: 3003916417-2017-00005
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 990418
• Device Lot Number: 6249170
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other