MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 1 ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE; TUBERCULIN SYRINGE AND NEEDLE

Catalog Number 309626

Device Problems Detachment Of Device Component (1104); Contamination (1120); Device Damaged Prior to Use (2284)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/18/2017

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported by a consumer that she had an issue with "contaminated" fluid in a 1 ml bd¿ tuberculin syringe with 25 g x 5/8 in.Bd precisionglide¿ detachable needle.The issue was found prior to use.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: sample evaluation: one open 1ml packaged syringe with needle was received by bd (b)(4) and confirmed to be from batch #7215560 (p/n 309626).The sample was visually evaluated.The syringe was found to have liquid drops in the fluid path.The liquid drops appear to be reddish in tint.The sample was sent for ftir evaluation to flks.The sample was examined and exhibited dark liquid droplets on the surface of the barrel tip and on the inner surface of the hub.A few minutes after removing the needle from the barrel, the dark liquid droplets crystallized and formed solid material.As per request, a small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that the material is most likely a type of medication (carboxymethylcellulose sodium salt and a glycol derivative shown for comparison).Based on the sample evaluation, the fluid observed cannot be confirmed to have originated during the manufacturing process.It appears that the sample had been manipulated prior to its return for evaluation.Dhr review for batch 7215560 (p/n 309626): manufacturing date: 08/04/2017 to 08/05/2017.Batch quantity was (b)(4).All visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 7215560 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Investigation conclusion: root cause and capa not required as not defects were confirmed.

• Brand Name: 1 ML BD¿ TB SYRINGE WITH 25 G X 5/8 IN. BD PRECISIONGLIDE¿ DETACHABLE NEEDLE
• Type of Device: TUBERCULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7187695
• MDR Text Key: 97546039
• Report Number: 1213809-2017-00437
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096269
• UDI-Public: 30382903096269
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2018

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?: Yes
• Device Operator: Nurse
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 309626
• Device Lot Number: 7215560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2017
• 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