MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB; PISTON SYRINGE

Model Number	305789
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 1ml ll w/ndl eclipse 27x1/2 rb leaked on 4 occasions during use.The following information was provided by the initial reporter: material no: 305789 batch no: 9361605.It was reported that the tip of the syringe where you attach the needle is not flat and leaks out.
Event or Problem Description
It was reported that syringe 1ml ll w/ndl eclipse 27x1/2 rb leaked on 4 occasions during use.The following information was provided by the initial reporter: material no: 305789 batch no: 9361605 it was reported that the tip of the syringe where you attach the needle is not flat and leaks out.305945, lot #: 9269166h- "bent at the tip upon placement in the pt." occurred on (b)(6) 2020 305789 lot #:9361605 -"tip of the syringe where you attatch the needle is not flat, warped plastic didn't get molded straight across and it leaked." customer stated they have 4 products like this.Occurred on (b)(6) 2020.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b.5.Describe event or problem: it was reported that syringe 1ml ll w/ndl eclipse 27x1/2 rb leaked on 4 occasions during use.The following information was provided by the initial reporter: material no: 305789 batch no: 9361605 it was reported that the tip of the syringe where you attach the needle is not flat and leaks out.305945, lot #: 9269166h- "bent at the tip upon placement in the pt." occurred on (b)(6) 2020 305789 lot #:9361605 -"tip of the syringe where you attatch the needle is not flat, warped plastic didn't get molded straight across and it leaked." customer stated they have 4 products like this.Occurred on (b)(6) 2020 d.10.Device available for eval?: yes d.10.Returned to manufacturer on: 9/23/2020 h.6.Investigation: one sample was received by our quality team for evaluation.The sample was subjected to visual inspection and short molding was observed on the syringe collar.Therefore, the team was able to confirm the customer experience.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.The sample was sent to the supplier plant for further investigation.The potential root cause for this defect is associated with the molding process.It is possible there was an issue with the gate causing the cavity to not fill properly.See h.10.

• Brand Name: SYRINGE 1ML LL W/NDL ECLIPSE 27X1/2 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10448162
• Report Number: 8041187-2020-00515
• Device Sequence Number: 2578172
• Product Code: FMF
• UDI-Device Identifier: 30382903057895
• UDI-Public: 30382903057895
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K941562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/31/2024
• Device Model Number: 305789
• Device Catalogue Number: 305789
• Device Lot Number: 9361605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Initial Date Received by Manufacturer: 08/04/2020
• Supplement Date Received by Manufacturer: 08/04/2020
• Initial Report FDA Received Date: 08/25/2020
• Supplement Report FDA Received Date: 10/20/2020
• 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