MAUDE Adverse Event Report: BD BD POSIFLUSH; PREFILLED FLUSH SYRINGES

Catalog Number 306546

Device Problem Crack (1135)

Patient Problem Exposure to Body Fluids (1745)

Event Date 03/07/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the reporter that the syringe was cracked in multiple areas and saline tinged with blood splashed in an associate's eyes.Cracked rim on a syringe cut an associate.Add'l info rec'd via email on (b)(4) 2014, the reporter stated that there was no medical intervention to the patient but the employee did receive treatment for the splash in the eye.No further info is available.

Manufacturer Narrative

Rec'd (b)(4) bd 10ml saline filled syringe (cat # 306546, lot # 3318138) within packages.(b)(4) of the returned samples were unopened, returned in a white bag, while a sealed box of add'l (b)(4) samples was rec'd.All of the returned samples were visually examined and no damage or deformity of the plunger, stopper or syringe barrel was observed on (b)(4) of the returned (b)(4) samples.The flange of the syringe was broken on one of the returned samples.This complaint is confirmed based on sample investigation.The incident has been added to our database and the lot number and issue will be tracked for emerging trends.

• Brand Name: BD POSIFLUSH
• Type of Device: PREFILLED FLUSH SYRINGES
• Manufacturer (Section D): BD; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BD; industrial site; columbus NE 68602
• Manufacturer Contact: elizabeth closner, rn, bsn ; 1 becton dr.; franklin lakes, NJ 07417 ; 2105265165
• MDR Report Key: 3769996
• MDR Text Key: 20659481
• Report Number: 2243072-2014-00064
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 306546
• Device Lot Number: 3318138
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/26/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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): Required Intervention