MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) NEEDLE ECLIPSE 21X1 RB TW; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305764
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 package damage occurred before use with a needle eclipse 21x1 rb tw.The following information was provided by the initial reporter, "during the packaging on (b)(6) 2019, needle 21 gauge i" bd eclipse (vendor lot 849969) was noted to have multiple punctures of the pouch for 2 sleeves.The defect is such that it questions the sterility of the product received from bd." 2 occurrences were reported.
Additional Manufacturer Narrative
Visual inspection: ¿ the 10 actual samples were subjected to visual inspection to check for damage package.¿ observed damage package on 2 out of 10 samples (refer to figure 2) which coincides with the eclipse safety shield location.With the damage on the package coincides with eclipse safety shield location, the damage could possibly been due to product out of pocket.If the eclipse product is not seated properly inside the blister pocket, during the sealing process at the primary packaging machine, the protruding part which could be the safety shield will damage the topweb packaging.There is an ¿out of pocket¿ sensor at the primary packaging to detect part out of pocket.Verified the sensor and it was able to detect part out of pocket.The damage top web packaging may also possible be caused during transportation or product handling.Dhr for packaged needle was performed for batch 7237425 the batch was built with packaging machine in sep 2017 there were no damage package rejects at the outgoing inspection no quality notification was raised for past 12 months on similar reported defects.
Event or Problem Description
It was reported that package damage occurred before use with a needle eclipse 21x1 rb tw.The following information was provided by the initial reporter, "during the packaging on (b)(6) 2019, needle 21 gauge i" bd eclipse (vendor lot 849969) was noted to have multiple punctures of the pouch for 2 sleeves.The defect is such that it questions the sterility of the product received from bd." 2 occurrences were reported.

• Brand Name: NEEDLE ECLIPSE 21X1 RB TW
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8798392
• Report Number: 8041187-2019-00549
• Device Sequence Number: 3205842
• Product Code: FMI
• UDI-Device Identifier: 30382903057642
• UDI-Public: 30382903057642
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K161170
• 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): 09/18/2019

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: 08/31/2022
• Device Catalogue Number: 305764
• Device Lot Number: 7237425
• Initial Date Received by Manufacturer: 06/25/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 09/18/2019
• 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