MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD SYRINGE 5ML LS

Model Number	305855
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported lot# 9266694 was not found for the catalog number.Device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was found at an unspecified time with a 5 ml bd¿ enteral syringe with clear barrel & bd univia¿ connector.The following information was provided by the initial reporter, "5ml syringe was found to have a small clear plastic piece inside the barrel of the syringe above the plunger stopper.".
Event or Problem Description
It was reported that foreign matter was found at an unspecified time with a bd syringe 5ml ls.The following information was provided by the initial reporter, "5ml syringe was found to have a small clear plastic piece inside the barrel of the syringe above the plunger stopper.".
Additional Manufacturer Narrative
Correction: the catalog and lot numbers have been updated by the customer.The following fields have been corrected: b.5.Describe event or problem: it was reported that foreign matter was found at an unspecified time with a bd syringe 5ml ls.The following information was provided by the initial reporter, "5ml syringe was found to have a small clear plastic piece inside the barrel of the syringe above the plunger stopper." d.4.Medical device lot #: 9266694, d.4.Medical device expiration date: 2024-09-30, h.4.Device manufacture date: 2019-09-23, d.1.Medical device brand name: bd syringe 5ml ls.D.1 medical device type: n/a d.2.Common device: syringe d.3.Medical device manufacturer: becton dickinson medical (singapore) d.4 medical device catalog #: 302130, d.4.Unique identifier (udi) #: (b)(4), g.2 manufacturing location: becton dickinson medical (singapore) d.10.Device available for eval?: yes d.10 returned to manufacturer on: 2020-04-13 h3 other text : see h.10.
Additional Manufacturer Narrative
H.6.Investigation: one photo and one actual sample were received by our quality team for evaluation.Upon visual inspection, it was observed that there was a solid plastic piece inside the syringe barrel.The solid pieces were the same diameter as the plunger.The incident could be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the investigation, this could be chip off of plunger dimension c; thereafter stuck at stopper lower tooling, when stopper feed into lower tooling, there is tendency the chip off pp stick to the stopper and get assembled.
Event or Problem Description
It was reported that foreign matter was found at an unspecified time with a bd syringe 5ml ls.The following information was provided by the initial reporter, "5ml syringe was found to have a small clear plastic piece inside the barrel of the syringe above the plunger stopper.".

• Brand Name: BD SYRINGE 5ML LS
• Common Device Name: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore CT 06018
• MDR Report Key: 9950275
• Report Number: 1213809-2020-00242
• Device Sequence Number: 19557564
• Product Code: KNT
• UDI-Device Identifier: 30382903058557
• UDI-Public: 30382903058557
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/01/2020

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2024
• Device Model Number: 305855
• Device Catalogue Number: 302130
• Device Lot Number: 9266694
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Initial Date Received by Manufacturer: 03/19/2020
• Supplement Date Received by Manufacturer: 03/19/2020; 03/19/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 05/08/2020; 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other