Catalog Number 303310 |
Device Problem
Packaging Problem (3007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/14/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0015659, medical device expiration date: 2025-01-31, device manufacture date: (b)(6) 2020.Medical device lot #: 0098739, medical device expiration date: 2025-04-30, device manufacture date: (b)(6) 2020.Medical device lot #: 0290115, medical device expiration date: 2025-10-31, device manufacture date: (b)(6) 2020.The customer's address is unknown.New jersey (nj), usa has been used as a default.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that syringe 20ml ll s/c 50 packaging ripped and contaminated the sterile field.The following information was provided by the initial reporter: material no.: 303310, batch no.: 0015659, 0098739, 0161042.It was reported that packaging splits and rips when opening, contaminating the sterile field.
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Event Description
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It was reported that syringe 20ml ll s/c 50 packaging ripped and contaminated the sterile field.The following information was provided by the initial reporter: material no.: 303310 batch no.: 0015659, 0098739, 0161042.It was reported that packaging splits and rips when opening, contaminating the sterile field.
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Manufacturer Narrative
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H6: investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.H3 other text : see h10.
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Search Alerts/Recalls
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