MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; PISTON SYRINGE

Catalog Number	305764
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: 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 after "bicillin la" was administered with the needle eclipse 21x1 rb tw, the safety shield broke off when attempting to cover the needle.The following information was provided by the initial reporter: the site is in receipt of a marked product complaint identifying a needle that was supplied was dull.The user reported that the needle was more difficult to push through.The customer stated that the bicillin la was administered successfully and no complications occurred.The customer also stated that the safety shield broke off when closing.Bd eclipse needle 21 gauge 1" (vendor lot: 7176188) were used to package bicillin la 1ml batch w0783.
Additional Manufacturer Narrative
H.6.Investigation: a review of past 12 months quality notification were performed and no quality notification was raised on the reported defects.The reported defects cannot be confirmed as no photo / samples were returned for investigation.Therefore, root cause could not be determined.
Event or Problem Description
It was reported that after "bicillin la" was administered with the needle eclipse 21x1 rb tw, the safety shield broke off when attempting to cover the needle.The following information was provided by the initial reporter: the site is in receipt of a marked product complaint identifying a needle that was supplied was dull.The user reported that the needle was more difficult to push through.The customer stated that the bicillin la was administered successfully and no complications occurred.The customer also stated that the safety shield broke off when closing.Bd eclipse needle 21 gauge 1" (vendor lot: 7176188) were used to package bicillin la 1ml batch w0783.

• Brand Name: NEEDLE ECLIPSE 21X1 RB TW
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8539880
• Report Number: 8041187-2019-00315
• Device Sequence Number: 10841230
• Product Code: FMF
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K980987
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 06/30/2022
• Device Catalogue Number: 305764
• Device Lot Number: 7176188
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 04/05/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/08/2019
• 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